MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARMS; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Skin Irritation (2076)

Event Date 08/04/2019

Event Type  Injury  

Event Description

After using the malem alarm for 3 nights, my daughter has developed an itch and rash on her body.The rash is exactly where the alarm is placed.She is in pain from small blisters that have appeared at that point.The logical conclusion is that the alarm is causing this issue.It is clamped tightly to her clothing and body there.It gets too hot and that could be the cause of blisters.Stopped using the alarm and contacted malem.No response.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARMS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8879295
• MDR Text Key: 153987633
• Report Number: MW5088911
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR